A Phase II Clinical Study of PDC-748 in Patients With Acute Cough
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|ClinicalTrials.gov Identifier: NCT00547846|
Recruitment Status : Completed
First Posted : October 23, 2007
Last Update Posted : January 12, 2009
The pharmacological effects of PDC-748 were tested in numerous in vitro and in vivo studies. The existing pharmacologic findings suggest that PDC-748 possesses certain inhibitory activity to the citric acid- and capsaicin-induced cough reflex in guinea pigs with a dose-dependent manner. Furthermore, a previous Phase I/II uncontrolled, dose-escalating study has shown PDC-748 to be well tolerated and may help to alleviate daytime cough with a dose-responding manner.Hence, PhytoHealth Corporation intends to carry out a Phase II investigation to confirm the preliminary findings using placebo in the comparator group, and to further investigate PDC-748 with a dose escalating manner to establish the dose-response range for its antitussive effect, and if possible, to determine the maximal tolerable dose of PDC-748.
This is a randomized, double-blind, placebo-controlled, dose escalating study to evaluate the safety and efficacy of the escalating dose levels of PDC-748 in patients with acute cough.
|Condition or disease||Intervention/treatment||Phase|
|Acute Cough||Drug: PDC-748||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Factorial Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Phase II Clinical Study of PDC-748 in Patients With Acute Cough|
|Study Start Date :||October 2007|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00547846
|Chang-Gung Memorial Hospital,Taiwan|
|Taipei city/ Taoyuan County, Taiwan,ROC, Taiwan, 105|
|Principal Investigator:||Ying-Huang Tsai, M.D.||Chang Gung Memorial Hospital|
|Principal Investigator:||Ying Huang Tsai, PI||Chang Gung Memorial Hospital|